EP2571548B1 - Compressible tubes for placing implants and related medical kits and methods of using same - Google Patents
Compressible tubes for placing implants and related medical kits and methods of using same Download PDFInfo
- Publication number
- EP2571548B1 EP2571548B1 EP11783973.8A EP11783973A EP2571548B1 EP 2571548 B1 EP2571548 B1 EP 2571548B1 EP 11783973 A EP11783973 A EP 11783973A EP 2571548 B1 EP2571548 B1 EP 2571548B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tube
- needle
- implant
- medical
- segment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000007943 implant Substances 0.000 title claims description 112
- 238000000034 method Methods 0.000 title claims description 18
- 239000000835 fiber Substances 0.000 claims description 86
- 229920001436 collagen Polymers 0.000 claims description 53
- 102000008186 Collagen Human genes 0.000 claims description 52
- 108010035532 Collagen Proteins 0.000 claims description 52
- 210000002435 tendon Anatomy 0.000 claims description 24
- 210000004872 soft tissue Anatomy 0.000 claims description 23
- 230000008439 repair process Effects 0.000 claims description 19
- 210000003041 ligament Anatomy 0.000 claims description 13
- 230000007704 transition Effects 0.000 claims description 5
- 238000002513 implantation Methods 0.000 claims description 4
- 238000011065 in-situ storage Methods 0.000 claims description 3
- 230000006835 compression Effects 0.000 claims description 2
- 238000007906 compression Methods 0.000 claims description 2
- 238000011144 upstream manufacturing Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 description 24
- HCZKYJDFEPMADG-UHFFFAOYSA-N nordihydroguaiaretic acid Chemical compound C=1C=C(O)C(O)=CC=1CC(C)C(C)CC1=CC=C(O)C(O)=C1 HCZKYJDFEPMADG-UHFFFAOYSA-N 0.000 description 14
- 210000001519 tissue Anatomy 0.000 description 13
- 230000036571 hydration Effects 0.000 description 6
- 238000006703 hydration reaction Methods 0.000 description 6
- 230000008520 organization Effects 0.000 description 6
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 238000010276 construction Methods 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 230000004044 response Effects 0.000 description 3
- 230000000153 supplemental effect Effects 0.000 description 3
- 229920002994 synthetic fiber Polymers 0.000 description 3
- 239000012209 synthetic fiber Substances 0.000 description 3
- 229940124597 therapeutic agent Drugs 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 210000001724 microfibril Anatomy 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- 102000016284 Aggrecans Human genes 0.000 description 1
- 108010067219 Aggrecans Proteins 0.000 description 1
- 102000004954 Biglycan Human genes 0.000 description 1
- 108090001138 Biglycan Proteins 0.000 description 1
- 229940122361 Bisphosphonate Drugs 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 102000004237 Decorin Human genes 0.000 description 1
- 108090000738 Decorin Proteins 0.000 description 1
- 102000010834 Extracellular Matrix Proteins Human genes 0.000 description 1
- 108010037362 Extracellular Matrix Proteins Proteins 0.000 description 1
- 102000003974 Fibroblast growth factor 2 Human genes 0.000 description 1
- 108090000379 Fibroblast growth factor 2 Proteins 0.000 description 1
- 102000016359 Fibronectins Human genes 0.000 description 1
- 108010067306 Fibronectins Proteins 0.000 description 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- 108090000723 Insulin-Like Growth Factor I Proteins 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 108091005804 Peptidases Proteins 0.000 description 1
- 102000010780 Platelet-Derived Growth Factor Human genes 0.000 description 1
- 108010038512 Platelet-Derived Growth Factor Proteins 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 102000013275 Somatomedins Human genes 0.000 description 1
- 102000009618 Transforming Growth Factors Human genes 0.000 description 1
- 108010009583 Transforming Growth Factors Proteins 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 229910052586 apatite Inorganic materials 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000003190 augmentative effect Effects 0.000 description 1
- 230000003592 biomimetic effect Effects 0.000 description 1
- 150000004663 bisphosphonates Chemical class 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 229910000389 calcium phosphate Inorganic materials 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 235000011010 calcium phosphates Nutrition 0.000 description 1
- 239000002041 carbon nanotube Substances 0.000 description 1
- 229910021393 carbon nanotube Inorganic materials 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000005482 chemotactic factor Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000002788 crimping Methods 0.000 description 1
- 239000003431 cross linking reagent Substances 0.000 description 1
- 231100000599 cytotoxic agent Toxicity 0.000 description 1
- 239000002619 cytotoxin Substances 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 210000002744 extracellular matrix Anatomy 0.000 description 1
- 210000002950 fibroblast Anatomy 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- -1 for example Substances 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000002874 hemostatic agent Substances 0.000 description 1
- KIUKXJAPPMFGSW-MNSSHETKSA-N hyaluronan Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)C1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H](C(O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-MNSSHETKSA-N 0.000 description 1
- 229940099552 hyaluronan Drugs 0.000 description 1
- 229920002674 hyaluronan Polymers 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 239000012633 leachable Substances 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 230000000921 morphogenic effect Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 239000002070 nanowire Substances 0.000 description 1
- VSIIXMUUUJUKCM-UHFFFAOYSA-D pentacalcium;fluoride;triphosphate Chemical compound [F-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O VSIIXMUUUJUKCM-UHFFFAOYSA-D 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 239000004633 polyglycolic acid Substances 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000036573 scar formation Effects 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 210000000130 stem cell Anatomy 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000008467 tissue growth Effects 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0805—Implements for inserting tendons or ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06004—Means for attaching suture to needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/1146—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of tendons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00902—Material properties transparent or translucent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00942—Material properties hydrophilic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3666—Epithelial tissues other than skin
Definitions
- the invention relates to medical constructs.
- the fibers When placing certain soft-tissue type implants, such, as for example, collagen fiber implants, the fibers can expand upon hydration, which can make it difficult to place the implants in a desired orientation and/or position in the body. Also, the collagen fibers may be somewhat fragile and subject to breakage when unprotected, such as when using hemostat clamps.
- General background on implant techniques may be derived from US 4050100 (Barry ), which shows a needle /tube/implant construction for hair implants.
- Embodiments of the present invention are directed to medical devices with compressible tubes for placing medical constructs in the body.
- Embodiments of the invention are directed to medical delivery devices that include a needle and a tube.
- the tube includes a first segment that is attached to the needle and a second compressible and substantially impermeable segment that increases in size relative to the first segment and extends rearward of the needle.
- the second segment defines an open elongate interior channel adapted to loosely hold at least about 30% of a length of a flexible medical implant therein.
- the medical device can hold a flexible elongate medical implant with a length so that at least about 3 cm of the implant length is held in the compressible second segment interior channel.
- the medical implant can be slidably insertable into the second segment interior channel and can be loosely held inside the tube interior channel spaced apart from the needle during intrabody placement using the needle and tube.
- At least about 25%, typically at least about 30% of the length of the implant is held inside the compressible channel.
- the flexible medical implant can be a partially hydrated or dry twisted or braided collagen fiber implant that is loosely held inside an outer wall of the tube second segment enclosing the interior channel.
- the tube can have a forward end portion that resides in an interior chamber of a rearward portion of the needle.
- the tube can be swaged to the needle and has a smooth transition segment from the needle to the tube to inhibit snagging when inserted through soft tissue during surgical use.
- the tube can be attached to a drilled end needle.
- the needle can have a length and the first segment of the compressible tubing can extend snugly against a portion of the needle, (e.g., 1 cm or more, typically at least about 30% of the length of the needle).
- the device can further include an elongate flexible braided or twisted collagen fiber implant with at least about 3 cm of its length held loosely in a substantially straight arrangement inside the second segment of the compressible tube.
- the needle can be shank-less and have a constant diameter outer wall upstream from a tip portion thereof.
- An inner wall of the first segment of the tube can be affixed to the outer wall of the needle.
- the device can further include a dry or partially hydrated collagen fiber implant having a length that swells (increases fiber diameter or size when in the body), and the tube second segment can have a length that is sufficient to encase at least about 30% of the implant held therein.
- the tube can be formed of heat-shrink tubing that is heated to shrink to conform and affix to at least about 1 cm (in some embodiments 30%) of an outer wall of the needle.
- the medical implant can be a tendon or ligament repair implant having a suture with at least 3 cm of its length being held in the second segment of tube.
- the medical implant held in the second segment of the tube can be a length of substantially or entirely dry or partially hydrated biocompatible collagen fibers twisted or braided together that swell when exposed to a local fluidic environment in situ.
- the medical implant held in the second segment of the tube can include a plurality of long fibers derived from soluble collagen that are in a dry or partially hydrated state and arranged as parallel long fibers that are twisted and/or woven or braided together.
- the fibers can include NDGA-polymerized collagen fibers.
- the fibers can have a cross-sectional size, on average when dry, of between about 0.001 inches (0.025 mm) to about 0.2 inches (5 mm) (when dry, on average), wherein the implant has a number of strands of fibers that is between about 2-100, and wherein the number of fibers per strand is between about 2 to 1200.
- the medical implant can be for a ligament or tendon repair.
- the medical implant can be at least one of a suture or a cable that is configured to repair an acromioclavicular (AC) joint.
- AC acromioclavicular
- the tube can be configured so that compression of a portion of the second segment caused by contact with surrounding local structure during implantation into soft tissue temporarily compresses the tube to tightly hold the implant therein.
- kits for a ligament or tendon repair include a delivery device having a flexible compressible substantially impermeable tube with an open interior attached to a needle having increased structural rigidity relative to the flexible tube; and a length of tendon or ligament repair or replacement material comprising dry or partially hydrated synthetic collagen fibers releasably held in the open interior of the tube or provided as a separate component for insertion into the open interior channel.
- the repair or replacement material can be a twisted or braided construct of a plurality of collagen fibers.
- the delivery device and repair or replacement material are held in at least one sterile package.
- Still other embodiments are directed to methods of placing a medical construct in the body of a subject.
- the methods include: (a) providing a surgical delivery device comprising a needle attached to a compressible tube with an open interior channel, the compressible tube surrounding an elongate medical construct having a body with a length, wherein at least about 3 cm of the construct body length is held in the open interior channel of the tube, wherein the construct body swells when exposed to liquid in the body of a subject; (b) pulling the needle and tube through local intrabody structure; (c) compressing the tube and the medical construct in response to pressure applied from contact with local structure during the pulling step, thereby also pulling the portion of the medical construct held in the tube through the local structure; then (d) separating the medical construct from the tube after the compressing step by continuing to pull the tube after the tube has exited the local structure so that the medical construct is loosely held in the tube, thereby removing the tube from the medical construct and placing the medical implant in the body.
- the medical construct can include dry or partially hydrated fibers when held inside the tube that swell when hydrated in the body.
- the medical construct can include a plurality of strands of biocompatible collagen fibers having at least a portion that is braided or twisted.
- the method can further include inserting the needle in soft tissue before the pulling and compressing steps.
- the pulling can be carried out by pulling the needle and tube through the soft tissue.
- the compressing can be carried out so that the tube and the medical construct are compressed in response to pressure applied from contact with the soft tissue during the pulling step thereby also pulling the portion of the medical construct held in the tube through the soft tissue.
- the separating step can be carried out by continuing to pull the tube after the tube has exited the soft tissue so that the medical construct is loosely held in the tube thereby removing the tube from the medical construct and placing the medical implant in the body.
- Yet other embodiments are directed to methods of assembling a medical delivery device with an implant for intrabody placement.
- the methods include: (a) providing a needle attached to a compressible tube having an open interior channel that extends a distance away from the needle; and (b) slidably inserting a medical implant comprising non-hydrated or partially hydrated braided and/or twisted collagen fibers into the open interior channel of the tube so that the implant is loosely held therein for intrabody placement using the needle and tube.
- the implant can have a non-coated, non-tipped end, e.g., it may comprise a broomed end configuration.
- the length of repair or replacement material can include a twisted or braided construct of a plurality of collagen fibers.
- the delivery device and repair or replacement material can be held in at least one sterile package.
- the medical construct can include fibers that swell when hydrated in the body.
- the medical construct can include non-hydrated or partially hydrated strands of biocompatible collagen fibers having at least a portion that is braided or twisted.
- phrases such as “between X and Y” and “between about X and Y” should be interpreted to include X and Y.
- phrases such as “between about X and Y” mean “between about X and about Y.”
- phrases such as “from about X to Y” mean “from about X to about Y.”
- first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention.
- the sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.
- implantable medical product configured to repair or replace (at least a portion of) tissue, typically soft tissue, such as, for example, muscle, a natural tendon, ligament (e.g ., ACL), AC joint, or other skin or tissue of a mammalian subject (for veterinary or medical (human) applications).
- implantable means the device can be inserted, embedded, grafted or otherwise chronically attached or placed on or in a patient.
- the term "impermeable" with respect to the delivery system tube means that the device is resistant to liquid diffusion so as to inhibit undue swelling (e.g ., hydration) of any implant or construct material held therein during placement of the construct in a mammalian body.
- needle refers to a substantially rigid device that has a sharp leading end.
- loosely held means that the medical implant material can be slidably inserted into the tube and resides in the tube in a use configuration with a low engagement force, e.g. , the implant can be easily separated from the tube by pulling the end of the material not held by the tube or by pulling the needle end of the tube with a low tensile force while the material extending from the other end of the tube is held with a clamp or frictional engagement with local structure.
- the medical implant is not in snug abutting contact with an outer wall of the compressible tube.
- collagen fibers refers to natural and synthetic collagen-derived fiber materials.
- Collagen "microfibrils,” “fibrils,” and “natural fibers” refer to naturally-occurring structures found in a tendon. Microfibrils are about 3.5 to 50 nm in diameter. Fibrils are about 50 nm to 50 ⁇ m in diameter. Natural fibers are above 50 ⁇ m in diameter.
- a “synthetic fiber” refers to any fiber-like material that has been formed and/or chemically or physically created or altered from its naturally-occurring state. For example, an extruded fiber of fibrils formed from a digested tendon is a synthetic fiber, but a tendon fiber newly harvested from a mammal is a natural fiber.
- synthetic collagen fibers can include non-collagenous components, such as particulates, hydroxyapatite and other mineral phases, or drugs that facilitate tissue growth. See , U.S. Patent 6,821,530 .
- the compositions can contain carbon nano-tubes, zinc nano-wires, nano-crystalline diamond or other nano-scale particulates, and larger crystalline and non-crystalline particulates such as calcium phosphate, calcium sulfate, and apatite minerals.
- the fibers and/or constructs formed of the fibers can include compositions that contain therapeutic agents such as bisphosphonates, anti-inflammatory steroids, growth factors such as basic fibroblast growth factor, tumor growth factor beta, bone morphogenic proteins, platelet-derived growth factor, and insulin-like growth factors; chemotactic factors such fibronectin and hyaluronan; and extracellular matrix molecules such as aggrecan, biglycan, and decorin.
- therapeutic agents such as bisphosphonates, anti-inflammatory steroids, growth factors such as basic fibroblast growth factor, tumor growth factor beta, bone morphogenic proteins, platelet-derived growth factor, and insulin-like growth factors; chemotactic factors such fibronectin and hyaluronan; and extracellular matrix molecules such as aggrecan, biglycan, and decorin.
- the fibers and/or constructs can contain cells, engineered cells, stem cells, and the like, as well as combinations of the above.
- braided and woven and derivatives thereof mean structures that are braided and/or (inter)woven, interlaced and/or interlocked in any manner, with a plurality, typically three or more, fibers or bundles of fibers together, including manually or automatically woven, braided, knitted and/or knotted and combinations of these or other interlocking or interlaced constructions.
- the woven constructs may comprise a plurality of warp and weft fibers.
- the fibers are typically collagen derived fibers.
- the term "twisted" and derivatives thereof mean to entwine two or more strands of fibers, typically collagen derived fibers, into a single strand.
- the twisted configuration can be formed by serially turning the fibers/strands in a clockwise or counter clockwise direction to introduce a series of turns extending along a lengthwise direction, including manually or automatically twisting the fibers and/or fiber bundles.
- the strands can have a single fiber or multiple fibers.
- the construct typically formed or comprising long (e.g., between about 1 cm to about 1 m) synthetic collagen (derived from donor collagen fibrils) fibers, may have a substantially constant length, whether in the dry or partially hydrated configuration or the fully hydrated configuration but typically swell upon exposure to hydration relative to a size at a dehydrated or partially hydrated state as held inside the compressible tube during delivery.
- long (e.g., between about 1 cm to about 1 m) synthetic collagen (derived from donor collagen fibrils) fibers may have a substantially constant length, whether in the dry or partially hydrated configuration or the fully hydrated configuration but typically swell upon exposure to hydration relative to a size at a dehydrated or partially hydrated state as held inside the compressible tube during delivery.
- dry or “dehydrated” means the construct fibers have a moisture content that is substantially less than the moisture amount that is present when fully hydrated.
- partially hydrated means that the construct and/or fibers thereof have a moisture content that is less than about 50%, typically less than about 75% of the moisture content at full hydration, measured ex vivo after 24 hours in a saline bath at ambient conditions.
- FIG. 1 shows an example of a medical delivery device 10.
- the device 10 includes a needle 15 and a flexible tube 20.
- the tube 20 may be optically transmissive (e.g ., translucent or transparent) to allow a clinician to view the portion of the medical implant 50 held in the interior of the tube 20.
- the tube 20 may be impermeable to inhibit swelling (e.g ., hydration) of the implant material during positioning of the implant 50 ( Figure 3A ) in the body based on exposure to local conditions (body fluids) using the delivery device 10.
- the needle 15 can have one or two open ends or closed ends.
- the needle 15 may have an open or closed leading end with the leading end 15 l being sharp and relatively small for ease of insertion through local structure, such as, for example, soft tissue.
- the needle 15 may have a solid body or may have a hollow body ( e.g ., have a cannula configuration).
- the needle can be a drilled-end needle or fenestrated needle.
- the needle 15 can have an open proximal end 15e.
- the needle 15 may be formed from hypodermic tubing.
- the needle 15 may have a circular (cross-section) or other geometric configuration.
- the needle 15 may be a 12 gauge needle (e.g.
- the needle 15 can have a constant size or may taper from a forward end to a distal and/or medial section.
- the needle 15 is typically shank-less, e.g ., it does not require a smaller neck facing the implant in the tube 20 , but may optionally have a shank.
- An example of needle with a shank that is snugly attached to a small tipped leading edge of a suture is shown in U.S. Patent No. 5,259,845 .
- the tube 20 can be attached to the needle 15 in any suitable manner.
- the tube 20 can be attached to the needle 15 by inserting a forward or leading edge portion 20f of the tube into an interior 15i of the (hollow or open end) needle 15 .
- the two components 15, 20 can also be swaged together, similar to a suture needle.
- other attachment configurations may also be used, for example, adhesive attachment, ultrasonic bonding, crimping, heat shrink and the like.
- the attachment transition region "t" between the needle 15 and the larger tube 20 can be relatively smooth to facilitate ease of insertion (and anti-snagging) during use.
- Figures 2A and 2B illustrate alternate embodiments of the delivery device 10'.
- the device 10' includes a tube 20 that can be attached to an exterior surface or wall 15w of the needle.
- the tube 20 can be heat-shrink tubing that can be heated to shrink against and conformably attach to the outer wall of the needle 15w.
- the tube 20 can include a first segment 22 that snugly resides about the needle 15 and a larger elongate second segment 23 that defines an open channel and has a larger size that can loosely hold the implant for delivery and/or intrabody placement.
- the first segment 22 of the tube 20 can reside over at least a major portion of a length of the needle 15 .
- the needle 15 can have a length that is between at least 10-50% of the length of the second segment 23 of the tube extending rearward of the needle 15 .
- Figure 2B illustrates the tube 20 before heat shrinking and Figure 2A illustrates the tube 20 firmly attached to the needle 15 after heat shrinking.
- Figure 2A illustrates that the tubing 20 can extend close to, e.g. , adjacent, a forward/leading end of the needle 15 so that the tube 20 overlies at least a major portion of the length of the needle 15, with the heat shrink portion 20h typically residing over between about 20% to about 95% of the length of the needle, and more typically between about 30-70% of the length of the needle.
- the tube 20 can be configured to reside over a minor portion of the length of the needle and/or or a smaller length or portion of the tube 20 overlying the needle 15 may be heat-shrink attached to the needle 15 , such as, for example, at least about 1 cm.
- the needle 15 may have a length "L" ( Figure 2C ) that is between about 70-100% of the length of the second segment 23 of the tube 20 ( Figures 7 , 8 ). In other embodiments, the needle 15 may have a shorter length than that shown, such as 30 %, 20% or even 10% or less the length of the second segment 23 .
- the transition "t" between the end of the needle 15 and the larger tube 20 can be relatively smooth (a gradual increase in size). However, other larger, typically tapered, transitions can be used.
- the tube 20 can be configured to fit or accommodate the implant 50 and can, in some embodiments, loosely and releasably hold the implant 50 therein. As shown in Figure 2C , the leading end of the implant 50 can reside a distance "D" spaced apart from the trailing end of the needle, so as to be in non-abutting (non-compressive contact) relationship with both the outer wall of the tube thereat and the end of the needle.
- the tube 20 can, for example, have a diameter of between about 0.05 inches and about 0.5 inches (1.3 - 13 mm), typically between about 0.1 to about 0.2 inches (2.5 - 5 mm), for certain medical uses, such as, for example, soft tissue repairs, including tendon and/or ligament repairs. However, other dimensions and sizes may be used.
- the tube 20 can have a length sufficient to define an open interior channel that can encase between about 20-100 % of the implant 50 for delivery in the body, typically between about 30-70% of the length of the implant, including, for example about a leading half of the implant.
- the implant 50 can be provided in any desired length, typically between about 0.5 cm to about 50 cm, more typically between about 1 cm to 25 cm. In some embodiments, the implant 50 has a length between about 5 cm to about 25 cm, including between about and about 10 cm to about 15 cm or between about 15 to 20 cm.
- the implant 50 may have a width between about 0.05 to 8 cm, and is typically between about 1-3 cm.
- the implant 50 may have a thickness of between about 0.01 to about 30 mm, typically about 1-10 mm.
- the at least one suture 250 can extend at least about 1 inch (25 mm) off beyond each end of the ribbon body, typically between about 1-15 inches.
- the suture(s) 150 (where used) can be shorter on one end than the other (not shown).
- the implant 50 can include integrated sutures 250 that are woven into and extend over the entire length of the implant and beyond ( see, e.g. , Figure 4C ).
- a common tube 20 and/or needle 15 size can be used to place a plurality of different size constructs because the implant 50 is typically loosely held in the tube 20 .
- a 12 gauge needle (a diameter of about 0.08 inches, 20mm) with about a 0.0935 inch (2.4 mm) tube can be used to place a 108, 216 and 432 collagen fiber braid of various corresponding sizes.
- a more complete description of woven and braided collagen fiber constructs and methods of making same can be found in U.S. Patent Application Serial No. 11/964,745 ( US 8177839 B2 ).
- the tube 20 can be a thin polymeric material such as, for example, PTFE tubing.
- the term “thin” refers to tubing material that is between about 0.01 and about 0.0015 inches (0.25 and 0.04 mm) thick and may be even thinner. However, the tube 20 can include other polymers and/or be formed in other thicknesses.
- the tube 20 and/or needle 15 can be used with or without a lubricous biocompatible coating for ease of insertion.
- the biocompatible coating may also include therapeutic agents, such as anti-inflammatory and antibiotic materials.
- polymer refers to polymers, copolymers and derivatives and combinations thereof.
- Figure 2C illustrates the delivery device 10, 10' being used to place a construct 50 in soft tissue, such as a tendon. As shown, the device 10, 10' holds the elongate construct 50. Figure 2C also illustrates that the construct 50 may be a braided (mesh) fiber construct.
- Figure 2C illustrates that a portion of the construct 50 is held and/or resides in the tube 20 and a portion of the construct 50 trails/extends outside of and behind the tube 20 .
- the device 10, 10' can be used to pull the construct 50 through the soft tissue 90 out of an opening 91 formed by the needle 15 .
- surrounding structure e.g. , surrounding tissue
- Fc compressive force
- the compressive forces Fc e.g. , pressure
- the device 10, 10' and implant 50 can be easily disconnected when the tube is pulled after it exits the local structure 90.
- Figures 3A-3C illustrate a sequence of steps (steps 1-3) that can be used to place the implant 50 .
- the implant 50 can be a twisted implant 50t or braided implant 50b of fibers, such as, for example, twisted or braided long (typically at least 2 inches long) collagen fibers that are held in the tube 20 in a partially or totally dehydrated state, and that, when placed in the body swell upon hydration.
- the implant 50 can be planar or tubular.
- suitable twisted collagen fibers and methods of making same see , U.S. Patent Application 12/465,433 ( US 9216077 B2 ).
- Step 1 shows the device 10, 10' with the tube 20 compressed by local structure to grasp the implant 50t.
- Step 2 illustrates the tube 20 exiting the local structure (e.g ., soft tissue) via exit port 91 created by the needle 15 thereby removing the compressive force that held the implant 50t .
- Step 3 shows that the device 10, 10' can be easily separated from the implant 50 by pulling the device 10, 10' which, without the compressive forces applied by the surrounding tissue, allows the device 10, 10' to be removed from the implant 50t while the implant remains in the target tissue 90 with a portion extending through port 91 .
- Figure 3D illustrates that the delivery device 10, 10' can be used to make multiple entries and exits from local tissue, such as in two adjacent pieces of soft tissue 90a, 90b ( e.g. , created by a torn ligament or tendon) before releasing the delivery device 10, 10' from the implant material 50 .
- Figure 3D illustrates that the delivery device 10, 10' can be used to penetrate local tissue in multiple entry and exit positions (labeled as locations "1"-"8") and position the implant 50 to extend between the two pieces of local tissue 90a, 90b (such as a torn ligament or tendon) and be secured to both pieces.
- Figure 3E shows a simple single connection between the two pieces 90a, 90b.
- Figure 4A illustrates an example of a tendon repair with the implant material 50 in position based on the use of the delivery device 10, 10' .
- the implant 50 can include a fixation knot 51 , such as a nail knot defined by loops of a suture (such as a six loop nail knot).
- the knot 51 can be held in the tube 20 during delivery/implantation using the delivery device 10, 10' .
- Figure 4B illustrates the implant 50 shown in Figure 4A with a supplemental suture 150 .
- the supplemental suture 150 can be a #2 TiCron suture configured with Krackow stitches, such as about 6 on each side of the tear 90a, 90b to help stabilize the implant 50 in position and/or provide additional structural support at least during an initial healing period post surgery.
- the delivery device 10, 10' can also be used to place other implants.
- the delivery device may be configured to hold and deliver braided ribbons 50r with at least one integrated suture 250 that extends over the entire length L of the implant body and out from each end a distance L 4 .
- the extension length L 4 can be between 1-500 mm or even greater, but is typically between about 20-400 mm.
- collagen fiber ribbons with integrated sutures see co-pending, co-assigned, U.S. Provisional Application Serial No. 61/450,179 ( US 8986378 B2 ).
- the construct 50 can optionally include, e.g. , be coated, impregnated and/or amalgamated with, a gel or other material.
- the coating may be to promote fibroblasts, and/or comprise one or more of an anti-inflammatory agent, an antibiotic or other therapeutic agent.
- the construct 50 can be absorbed, resorbed and/or biodegradable over time.
- the constructs 50 can be configured to have similar or greater tensile strength, stiffness and dynamic flexibility as corresponding natural tissue, e.g ., natural ligament or tendon fibers.
- Embodiments of the invention may be particularly suitable for augmenting, repairing or replacing tendons and ligaments.
- the fibers comprise collagen fibers formed in any suitable manner to be acceptable as a biomedical implant/construct.
- the fibers can comprise NDGA-treated collagen. Suitable ways of forming NDGA-polymerized and/or - treated fibers are described in U.S. Patent Nos. 6,565,960 and 6,821,530 . Generally stated, bulk collagen can be solubilized by digestion with a protease, then extruded into a synthetic fiber. Properly processed NDGA polymerized fibers are biocompatible. After the polymerization process, the fibers can be washed in ethanol and phosphate buffered saline to remove cytotoxins due to leachable reaction products.
- NDGA-treated collagen fibers are biocompatible and have desirable mechanical properties.
- NDGA polymerized fibers see, Thomas J. Koob, Biomimetic approaches to Tendon Repair, Comparative Biochemistry and Physiology Part A 133 (2002) 1171-1192 .
- the collagen fibers may be high-strength.
- high-strength refers to fibers having an average tensile strength of at least about 150 MPa, such as between about 180 MPa and 350 MPa, and typically, for bovine-, porcine- or caprine-based "donor" collagen, between about 180 MPa and 280 MPa, such as between about 240-279 MPa (measured on average).
- the fibers may also have suitable stiffness and strain yield. In general, the fibers can have a stiffness of at least about 200 MPa ( e.g. , at least about 300, 400, 500, or 600 MPa), and a strain at failure of less than about 20% ( e.g. , less than about 15 or 10%).
- the fibers may be formed with a relatively thin diameter, such as, for example about a 0.07 mm dry diameter (on average) and about a 0.09 mm wet diameter (on average) or a dry diameter on average of about 0.08 mm and a wet diameter on average of about 0.13 mm.
- a relatively thin diameter such as, for example about a 0.07 mm dry diameter (on average) and about a 0.09 mm wet diameter (on average) or a dry diameter on average of about 0.08 mm and a wet diameter on average of about 0.13 mm.
- other sizes may be used.
- preparatory donor collagen material can be pepsin-derived or solubilized collagen that is processed/purified.
- the purified collagen preparatory material is dialyzed a plurality of times in a selected liquid for a desired period of time. The dialyzing is typically repeated three times.
- the dialyzing can be carried out against dionized (DI) water in a volume ratio of between about 30:1 to about 100:1, typically about 60:1, for between about 30-90 minutes, typically about 40 minutes.
- DI dionized
- the dialyzing can form a substantially clear gel of collagen fibrils indicating good organization (substantially parallel fibrils), where opacity indicates less organization. The organization can help improve tensile strength of subsequently cross-linked fibers.
- the dialyzed collagen material can be incubated for a desired time before placing in a fiber-forming buffer.
- the dialyzed gel can be cross-linked to provide collagen fibers for medical constructs.
- the polymerization e.g ., cross-linking
- the resultant collagen fibers can be relatively thin, such as, for example, about 0.08 mm dry diameter (on average).
- the incubation may be for at least about 24 hours, typically 24-48 hours, and may be at room temperature of between about 15-30° C, typically about 25° C.
- the dialysis process can be used before cross-linking for subsequent use with any suitable cross-linking materials, such as, for example, to promote collagen organization, and the process is not limited to NDGA, but may be useful with other materials, including, for example, glutaraldehyde.
- the implants 50 can include swellable collagen fibers that have a cross-sectional size, on average, when dry, of between about 0.001 inches to about 0.2 inches (0.025 to 5 mm).
- the implant can include a number of strands of collagen-derived fibers such as between about 2-100, and the number of fibers per strand can be between about 2 to 1200.
- the implant 50 may have between about 1-1000 yarns, typically between about 3-100 yarns some of which are weft and some of which are warp yarns.
- the implant 50 can be configured to have substantially the same physical thickness and/or configuration as the replaced or repaired tissue so as to not cause discomfort or physical abnormalities in structure.
- the body of the implant 50 can include a smooth outer sheath that may be formed by a coating, gel or other material.
- the implant 50 can comprise polyglycolic acid, polylactic acid, or combinations of these or other substances.
- Figure 5 illustrates a medical kit 75 that includes the delivery device 10, 10' and, optionally, at least one construct 50, in a sealed package 88 .
- the construct 50 may be held dehydrated or partially hydrated in the package 88 or in another separate package (not shown).
- the kit 75 may include a temperature warning so that the construct 50 is not exposed to unduly hot temperatures that may degrade the implant.
- a temperature sensor 80 may optionally be included on or in the package 88 of the kit 75 to provide a visual or audible alert to a clinician as to any excessive or undue temperature exposure prior to implantation.
- the construct 50 can be held in the tube 20 in the package 88 .
- the construct 50 can be inserted into the tube 20 of the device 10, 10' by the clinician in situ.
- the delivery device 10, 10' can be a "universal" delivery device that is configured to accommodate soft tissue implants in a range of sizes.
- FIG. 6 is a flow diagram of exemplary operations that can be used to carry out embodiments of the present invention.
- a flexible tube with an open interior channel attached to a needle and having an elongate medical construct having a length with a portion held in the open interior channel is provided (block 100 ).
- the needle and tube are pulled through local structure (block 105 ).
- the tube and the medical construct are compressed in response to pressure applied from contact with local structure during the pulling step, thereby also pulling the portion of the medical construct held in the tube through the local structure (block 110 ).
- the medical construct is then separated from the tube after the compressing step by continuing to pull the tube after the tube has exited the local structure so that the medical construct is loosely held in the tube, thereby removing the tube from the medical construct and placing the medical implant in the body (block 115 ).
- the local structure can optionally be soft tissue (block 107 ).
- the construct can optionally be loosely held in the tube and temporarily compressed by contact with the local structure (block 103 ).
- the delivery devices 10, 10' can deliver other types of implants.
- Figures 7 and 8 show a delivery device 10' with the tube 20 as a heat shrink tube and with the medical construct 50 formed with braided NDGA-collagen fibers.
- Figure 7 illustrates that the heat shrink portion 20h extends over more than half of the length L 1 of the needle 15 and that the second segment of the tube 23 has a length that is between about 60-100% that of the implant. As shown, the second segment 23 has a longer length L 2 than the length L 1 of the needle 15 .
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Rheumatology (AREA)
- Rehabilitation Therapy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
- This application claims the benefit of and priority to
U.S. Provisional Application Serial Number 61/345,292, filed May 17, 2010 - The invention relates to medical constructs.
- It is believed that the linear organization of natural collagen fibers in tendons results in optimal stiffness and strength at low strains under tensile loads. However, this organization makes repairing tissue such as ruptured or lacerated tendons difficult. Current suturing tech' to prevent gapping, are often inadequate to carry normal loads and may not ever allow the tendon to regain its original mechanical properties or mobility. Immobilization protocols used to restore tendon congruity may result in scar formation at the repair site and peripheral adhesions that can limit excursions. One or more similar issues may be associated with conventional ligament repair techniques.
- When placing certain soft-tissue type implants, such, as for example, collagen fiber implants, the fibers can expand upon hydration, which can make it difficult to place the implants in a desired orientation and/or position in the body. Also, the collagen fibers may be somewhat fragile and subject to breakage when unprotected, such as when using hemostat clamps. General background on implant techniques may be derived from
US 4050100 (Barry ), which shows a needle /tube/implant construction for hair implants. - Embodiments of the present invention are directed to medical devices with compressible tubes for placing medical constructs in the body.
- Embodiments of the invention are directed to medical delivery devices that include a needle and a tube. The tube includes a first segment that is attached to the needle and a second compressible and substantially impermeable segment that increases in size relative to the first segment and extends rearward of the needle. The second segment defines an open elongate interior channel adapted to loosely hold at least about 30% of a length of a flexible medical implant therein.
- The medical device can hold a flexible elongate medical implant with a length so that at least about 3 cm of the implant length is held in the compressible second segment interior channel. The medical implant can be slidably insertable into the second segment interior channel and can be loosely held inside the tube interior channel spaced apart from the needle during intrabody placement using the needle and tube.
- In some embodiments, at least about 25%, typically at least about 30% of the length of the implant is held inside the compressible channel.
- The flexible medical implant can be a partially hydrated or dry twisted or braided collagen fiber implant that is loosely held inside an outer wall of the tube second segment enclosing the interior channel.
- The tube can have a forward end portion that resides in an interior chamber of a rearward portion of the needle.
- The tube can be swaged to the needle and has a smooth transition segment from the needle to the tube to inhibit snagging when inserted through soft tissue during surgical use.
- The tube can be attached to a drilled end needle.
- The needle can have a length and the first segment of the compressible tubing can extend snugly against a portion of the needle, (e.g., 1 cm or more, typically at least about 30% of the length of the needle). The device can further include an elongate flexible braided or twisted collagen fiber implant with at least about 3 cm of its length held loosely in a substantially straight arrangement inside the second segment of the compressible tube.
- The needle can be shank-less and have a constant diameter outer wall upstream from a tip portion thereof. An inner wall of the first segment of the tube can be affixed to the outer wall of the needle. The device can further include a dry or partially hydrated collagen fiber implant having a length that swells (increases fiber diameter or size when in the body), and the tube second segment can have a length that is sufficient to encase at least about 30% of the implant held therein.
- The tube can be formed of heat-shrink tubing that is heated to shrink to conform and affix to at least about 1 cm (in some embodiments 30%) of an outer wall of the needle.
- The medical implant can be a tendon or ligament repair implant having a suture with at least 3 cm of its length being held in the second segment of tube.
- The medical implant held in the second segment of the tube can be a length of substantially or entirely dry or partially hydrated biocompatible collagen fibers twisted or braided together that swell when exposed to a local fluidic environment in situ.
- The medical implant held in the second segment of the tube can include a plurality of long fibers derived from soluble collagen that are in a dry or partially hydrated state and arranged as parallel long fibers that are twisted and/or woven or braided together.
- The fibers can include NDGA-polymerized collagen fibers.
- The fibers can have a cross-sectional size, on average when dry, of between about 0.001 inches (0.025 mm) to about 0.2 inches (5 mm) (when dry, on average), wherein the implant has a number of strands of fibers that is between about 2-100, and wherein the number of fibers per strand is between about 2 to 1200.
- The medical implant can be for a ligament or tendon repair.
- The medical implant can be at least one of a suture or a cable that is configured to repair an acromioclavicular (AC) joint.
- The tube can be configured so that compression of a portion of the second segment caused by contact with surrounding local structure during implantation into soft tissue temporarily compresses the tube to tightly hold the implant therein.
- Other embodiments are directed to medical kits for a ligament or tendon repair. The kits include a delivery device having a flexible compressible substantially impermeable tube with an open interior attached to a needle having increased structural rigidity relative to the flexible tube; and a length of tendon or ligament repair or replacement material comprising dry or partially hydrated synthetic collagen fibers releasably held in the open interior of the tube or provided as a separate component for insertion into the open interior channel.
- The repair or replacement material can be a twisted or braided construct of a plurality of collagen fibers. The delivery device and repair or replacement material are held in at least one sterile package.
- Still other embodiments are directed to methods of placing a medical construct in the body of a subject. The methods include: (a) providing a surgical delivery device comprising a needle attached to a compressible tube with an open interior channel, the compressible tube surrounding an elongate medical construct having a body with a length, wherein at least about 3 cm of the construct body length is held in the open interior channel of the tube, wherein the construct body swells when exposed to liquid in the body of a subject; (b) pulling the needle and tube through local intrabody structure; (c) compressing the tube and the medical construct in response to pressure applied from contact with local structure during the pulling step, thereby also pulling the portion of the medical construct held in the tube through the local structure; then (d) separating the medical construct from the tube after the compressing step by continuing to pull the tube after the tube has exited the local structure so that the medical construct is loosely held in the tube, thereby removing the tube from the medical construct and placing the medical implant in the body.
- The medical construct can include dry or partially hydrated fibers when held inside the tube that swell when hydrated in the body.
- The medical construct can include a plurality of strands of biocompatible collagen fibers having at least a portion that is braided or twisted.
- The method can further include inserting the needle in soft tissue before the pulling and compressing steps. The pulling can be carried out by pulling the needle and tube through the soft tissue. The compressing can be carried out so that the tube and the medical construct are compressed in response to pressure applied from contact with the soft tissue during the pulling step thereby also pulling the portion of the medical construct held in the tube through the soft tissue. The separating step can be carried out by continuing to pull the tube after the tube has exited the soft tissue so that the medical construct is loosely held in the tube thereby removing the tube from the medical construct and placing the medical implant in the body.
- Yet other embodiments are directed to methods of assembling a medical delivery device with an implant for intrabody placement. The methods include: (a) providing a needle attached to a compressible tube having an open interior channel that extends a distance away from the needle; and (b) slidably inserting a medical implant comprising non-hydrated or partially hydrated braided and/or twisted collagen fibers into the open interior channel of the tube so that the implant is loosely held therein for intrabody placement using the needle and tube.
- The implant can have a non-coated, non-tipped end, e.g., it may comprise a broomed end configuration.
- The length of repair or replacement material can include a twisted or braided construct of a plurality of collagen fibers. The delivery device and repair or replacement material can be held in at least one sterile package.
- The medical construct can include fibers that swell when hydrated in the body. The medical construct can include non-hydrated or partially hydrated strands of biocompatible collagen fibers having at least a portion that is braided or twisted.
- It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
- Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the embodiments that follow, such description being merely illustrative of the present invention.
-
-
Figure 1 is a side perspective view of a delivery device according to embodiments of the present invention. -
Figure 2A is a side perspective view of another delivery device according to embodiments of the present invention. -
Figure 2B is a side perspective view of the device shown inFigure 2A before heat shrinking. -
Figure 2C is a top view of the delivery device shown inFigure 2A shown in an exemplary use configuration according to some embodiments of the present invention. -
Figures 3A-C are views of a delivery device as inFigure 2A , shown in an exemplary use configuration according to embodiments of the present invention. -
Figure 3D is a schematic illustration of a delivery device that can be used to define multiple entry and exit points in local tissue according to embodiments of the present invention. -
Figure 3E is an illustration of the device being used to secure two adjacent pieces of tissue. -
Figure 4A is a schematic illustration of a tendon repair procedure according to some embodiments of the present invention. -
Figure 4B is a schematic illustration of a tendon repair procedure similar to that shown inFigure 4A but with an exemplary supplemental suture configuration according to some embodiments of the present invention. -
Figure 4C shows an alternate embodiment of a collagen fiber ribbon implant that can be placed using the delivery devices according to some embodiments of the present invention. -
Figure 5 is a schematic illustration of a medical kit according to embodiments of the present invention. -
Figure 6 is a flow chart of exemplary operations that can be used to carry out methods according to some embodiments of the present invention. -
Figure 7 is a side view of an exemplary delivery device adapted to hold a soft tissue implant according to embodiments of the present invention. -
Figure 8 is a side view of the delivery device enclosing a leading end of the implant shown inFigure 7 according to embodiments of the present invention. - The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
- Like numbers refer to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. In the figures, broken lines illustrate optional features or operations unless specified otherwise.
- The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."
- Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
- It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
- It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.
- The terms "implant," "prosthesis" and "construct" are used interchangeably herein to designate an implantable medical product configured to repair or replace (at least a portion of) tissue, typically soft tissue, such as, for example, muscle, a natural tendon, ligament (e.g., ACL), AC joint, or other skin or tissue of a mammalian subject (for veterinary or medical (human) applications). The term "implantable" means the device can be inserted, embedded, grafted or otherwise chronically attached or placed on or in a patient.
- The term "impermeable" with respect to the delivery system tube means that the device is resistant to liquid diffusion so as to inhibit undue swelling (e.g., hydration) of any implant or construct material held therein during placement of the construct in a mammalian body.
- The term "needle" refers to a substantially rigid device that has a sharp leading end.
- The term "loosely held" means that the medical implant material can be slidably inserted into the tube and resides in the tube in a use configuration with a low engagement force, e.g., the implant can be easily separated from the tube by pulling the end of the material not held by the tube or by pulling the needle end of the tube with a low tensile force while the material extending from the other end of the tube is held with a clamp or frictional engagement with local structure. The medical implant is not in snug abutting contact with an outer wall of the compressible tube.
- The term "collagen fibers" refers to natural and synthetic collagen-derived fiber materials. Collagen "microfibrils," "fibrils," and "natural fibers" refer to naturally-occurring structures found in a tendon. Microfibrils are about 3.5 to 50 nm in diameter. Fibrils are about 50 nm to 50 µm in diameter. Natural fibers are above 50 µm in diameter. A "synthetic fiber" refers to any fiber-like material that has been formed and/or chemically or physically created or altered from its naturally-occurring state. For example, an extruded fiber of fibrils formed from a digested tendon is a synthetic fiber, but a tendon fiber newly harvested from a mammal is a natural fiber. Of course, synthetic collagen fibers can include non-collagenous components, such as particulates, hydroxyapatite and other mineral phases, or drugs that facilitate tissue growth. See,
U.S. Patent 6,821,530 . For example, the compositions can contain carbon nano-tubes, zinc nano-wires, nano-crystalline diamond or other nano-scale particulates, and larger crystalline and non-crystalline particulates such as calcium phosphate, calcium sulfate, and apatite minerals. For example, the fibers and/or constructs formed of the fibers can include compositions that contain therapeutic agents such as bisphosphonates, anti-inflammatory steroids, growth factors such as basic fibroblast growth factor, tumor growth factor beta, bone morphogenic proteins, platelet-derived growth factor, and insulin-like growth factors; chemotactic factors such fibronectin and hyaluronan; and extracellular matrix molecules such as aggrecan, biglycan, and decorin. In some embodiments, the fibers and/or constructs can contain cells, engineered cells, stem cells, and the like, as well as combinations of the above. - The term "flexible" means that the so-called member can be flexed or bent.
- The terms "braided" and "woven" and derivatives thereof mean structures that are braided and/or (inter)woven, interlaced and/or interlocked in any manner, with a plurality, typically three or more, fibers or bundles of fibers together, including manually or automatically woven, braided, knitted and/or knotted and combinations of these or other interlocking or interlaced constructions. The woven constructs may comprise a plurality of warp and weft fibers. The fibers are typically collagen derived fibers.
- The term "twisted" and derivatives thereof mean to entwine two or more strands of fibers, typically collagen derived fibers, into a single strand. The twisted configuration can be formed by serially turning the fibers/strands in a clockwise or counter clockwise direction to introduce a series of turns extending along a lengthwise direction, including manually or automatically twisting the fibers and/or fiber bundles. The strands can have a single fiber or multiple fibers.
- The construct, typically formed or comprising long (e.g., between about 1 cm to about 1 m) synthetic collagen (derived from donor collagen fibrils) fibers, may have a substantially constant length, whether in the dry or partially hydrated configuration or the fully hydrated configuration but typically swell upon exposure to hydration relative to a size at a dehydrated or partially hydrated state as held inside the compressible tube during delivery.
- The term "dry" or "dehydrated" means the construct fibers have a moisture content that is substantially less than the moisture amount that is present when fully hydrated. The term "partially hydrated" means that the construct and/or fibers thereof have a moisture content that is less than about 50%, typically less than about 75% of the moisture content at full hydration, measured ex vivo after 24 hours in a saline bath at ambient conditions.
- Referring now to the figures,
Figure 1 shows an example of amedical delivery device 10. Thedevice 10 includes aneedle 15 and aflexible tube 20. Thetube 20 may be optically transmissive (e.g., translucent or transparent) to allow a clinician to view the portion of themedical implant 50 held in the interior of thetube 20. Thetube 20 may be impermeable to inhibit swelling (e.g., hydration) of the implant material during positioning of the implant 50 (Figure 3A ) in the body based on exposure to local conditions (body fluids) using thedelivery device 10. - The
needle 15 can have one or two open ends or closed ends. Theneedle 15 may have an open or closed leading end with the leading end 15l being sharp and relatively small for ease of insertion through local structure, such as, for example, soft tissue. Theneedle 15 may have a solid body or may have a hollow body (e.g., have a cannula configuration). The needle can be a drilled-end needle or fenestrated needle. Theneedle 15 can have an openproximal end 15e. Theneedle 15 may be formed from hypodermic tubing. Theneedle 15 may have a circular (cross-section) or other geometric configuration. Theneedle 15 may be a 12 gauge needle (e.g., have a forward end of about 0.08 inches or less, such as between about 0.04 to about 0.08 inches) (1-2 mm) and thetube 20 may be slightly larger. Theneedle 15 can have a constant size or may taper from a forward end to a distal and/or medial section. Theneedle 15 is typically shank-less, e.g., it does not require a smaller neck facing the implant in thetube 20, but may optionally have a shank. An example of needle with a shank that is snugly attached to a small tipped leading edge of a suture is shown inU.S. Patent No. 5,259,845 . - The
tube 20 can be attached to theneedle 15 in any suitable manner. In the embodiment shown inFigure 1 , thetube 20 can be attached to theneedle 15 by inserting a forward or leadingedge portion 20f of the tube into an interior 15i of the (hollow or open end)needle 15. The twocomponents needle 15 and thelarger tube 20 can be relatively smooth to facilitate ease of insertion (and anti-snagging) during use. -
Figures 2A and 2B illustrate alternate embodiments of the delivery device 10'. As shown, the device 10' includes atube 20 that can be attached to an exterior surface orwall 15w of the needle. In some embodiments, thetube 20 can be heat-shrink tubing that can be heated to shrink against and conformably attach to the outer wall of theneedle 15w. Thetube 20 can include afirst segment 22 that snugly resides about theneedle 15 and a larger elongatesecond segment 23 that defines an open channel and has a larger size that can loosely hold the implant for delivery and/or intrabody placement. Where thetube 20 is mounted to an exterior surface of theneedle 15, thefirst segment 22 of thetube 20 can reside over at least a major portion of a length of theneedle 15. In some embodiments, theneedle 15 can have a length that is between at least 10-50% of the length of thesecond segment 23 of the tube extending rearward of theneedle 15. -
Figure 2B illustrates thetube 20 before heat shrinking andFigure 2A illustrates thetube 20 firmly attached to theneedle 15 after heat shrinking.Figure 2A illustrates that thetubing 20 can extend close to, e.g., adjacent, a forward/leading end of theneedle 15 so that thetube 20 overlies at least a major portion of the length of theneedle 15, with theheat shrink portion 20h typically residing over between about 20% to about 95% of the length of the needle, and more typically between about 30-70% of the length of the needle. - In other embodiments, the
tube 20 can be configured to reside over a minor portion of the length of the needle and/or or a smaller length or portion of thetube 20 overlying theneedle 15 may be heat-shrink attached to theneedle 15, such as, for example, at least about 1 cm. - The
needle 15 may have a length "L" (Figure 2C ) that is between about 70-100% of the length of thesecond segment 23 of the tube 20 (Figures 7 ,8 ). In other embodiments, theneedle 15 may have a shorter length than that shown, such as 30 %, 20% or even 10% or less the length of thesecond segment 23. As before, the transition "t" between the end of theneedle 15 and thelarger tube 20 can be relatively smooth (a gradual increase in size). However, other larger, typically tapered, transitions can be used. - The
tube 20 can be configured to fit or accommodate theimplant 50 and can, in some embodiments, loosely and releasably hold theimplant 50 therein. As shown inFigure 2C , the leading end of theimplant 50 can reside a distance "D" spaced apart from the trailing end of the needle, so as to be in non-abutting (non-compressive contact) relationship with both the outer wall of the tube thereat and the end of the needle. Thetube 20 can, for example, have a diameter of between about 0.05 inches and about 0.5 inches (1.3 - 13 mm), typically between about 0.1 to about 0.2 inches (2.5 - 5 mm), for certain medical uses, such as, for example, soft tissue repairs, including tendon and/or ligament repairs. However, other dimensions and sizes may be used. - The
tube 20 can have a length sufficient to define an open interior channel that can encase between about 20-100 % of theimplant 50 for delivery in the body, typically between about 30-70% of the length of the implant, including, for example about a leading half of the implant. Theimplant 50 can be provided in any desired length, typically between about 0.5 cm to about 50 cm, more typically between about 1 cm to 25 cm. In some embodiments, theimplant 50 has a length between about 5 cm to about 25 cm, including between about and about 10 cm to about 15 cm or between about 15 to 20 cm. Theimplant 50 may have a width between about 0.05 to 8 cm, and is typically between about 1-3 cm. Theimplant 50 may have a thickness of between about 0.01 to about 30 mm, typically about 1-10 mm. The at least onesuture 250 can extend at least about 1 inch (25 mm) off beyond each end of the ribbon body, typically between about 1-15 inches. The suture(s) 150 (where used) can be shorter on one end than the other (not shown). Theimplant 50 can includeintegrated sutures 250 that are woven into and extend over the entire length of the implant and beyond (see, e.g.,Figure 4C ). - A
common tube 20 and/orneedle 15 size can be used to place a plurality of different size constructs because theimplant 50 is typically loosely held in thetube 20. For example, a 12 gauge needle (a diameter of about 0.08 inches, 20mm) with about a 0.0935 inch (2.4 mm) tube can be used to place a 108, 216 and 432 collagen fiber braid of various corresponding sizes. A more complete description of woven and braided collagen fiber constructs and methods of making same can be found inU.S. Patent Application Serial No. 11/964,745 (US 8177839 B2 ). - The
tube 20 can be a thin polymeric material such as, for example, PTFE tubing. The term "thin" refers to tubing material that is between about 0.01 and about 0.0015 inches (0.25 and 0.04 mm) thick and may be even thinner. However, thetube 20 can include other polymers and/or be formed in other thicknesses. Thetube 20 and/orneedle 15 can be used with or without a lubricous biocompatible coating for ease of insertion. The biocompatible coating may also include therapeutic agents, such as anti-inflammatory and antibiotic materials. The term "polymer" refers to polymers, copolymers and derivatives and combinations thereof. -
Figure 2C illustrates thedelivery device 10, 10' being used to place aconstruct 50 in soft tissue, such as a tendon. As shown, thedevice 10, 10' holds theelongate construct 50.Figure 2C also illustrates that theconstruct 50 may be a braided (mesh) fiber construct. -
Figure 2C illustrates that a portion of theconstruct 50 is held and/or resides in thetube 20 and a portion of theconstruct 50 trails/extends outside of and behind thetube 20. Thedevice 10, 10' can be used to pull theconstruct 50 through thesoft tissue 90 out of anopening 91 formed by theneedle 15. As thetube 20 passes through thelocal structure 90, e.g., surrounding structure (e.g., surrounding tissue) applies a compressive force "Fc" to the body of thetube 20 thereby firmly grasping theimplant material 50 therein. After thetube 20 exits the local structure, e.g.,soft tissue 90, the compressive forces Fc (e.g., pressure) on thetube 20 automatically abate, e.g., stop. Thedevice 10, 10' andimplant 50 can be easily disconnected when the tube is pulled after it exits thelocal structure 90. -
Figures 3A-3C illustrate a sequence of steps (steps 1-3) that can be used to place theimplant 50. The figures also illustrate that theimplant 50 can be atwisted implant 50t or braidedimplant 50b of fibers, such as, for example, twisted or braided long (typically at least 2 inches long) collagen fibers that are held in thetube 20 in a partially or totally dehydrated state, and that, when placed in the body swell upon hydration. Theimplant 50 can be planar or tubular. For a more complete description of suitable twisted collagen fibers and methods of making same, see,U.S. Patent Application 12/465,433 (US 9216077 B2 - Step 1 (
Figure 3A ) shows thedevice 10, 10' with thetube 20 compressed by local structure to grasp theimplant 50t. Step 2 (Figure 3B ) illustrates thetube 20 exiting the local structure (e.g., soft tissue) viaexit port 91 created by theneedle 15 thereby removing the compressive force that held theimplant 50t. Step 3 (Figure 3C ) shows that thedevice 10, 10' can be easily separated from theimplant 50 by pulling thedevice 10, 10' which, without the compressive forces applied by the surrounding tissue, allows thedevice 10, 10' to be removed from theimplant 50t while the implant remains in thetarget tissue 90 with a portion extending throughport 91. -
Figure 3D illustrates that thedelivery device 10, 10' can be used to make multiple entries and exits from local tissue, such as in two adjacent pieces ofsoft tissue delivery device 10, 10' from theimplant material 50. -
Figure 3D illustrates that thedelivery device 10, 10' can be used to penetrate local tissue in multiple entry and exit positions (labeled as locations "1"-"8") and position theimplant 50 to extend between the two pieces oflocal tissue Figure 3E shows a simple single connection between the twopieces -
Figure 4A illustrates an example of a tendon repair with theimplant material 50 in position based on the use of thedelivery device 10, 10'. As shown, theimplant 50 can include afixation knot 51, such as a nail knot defined by loops of a suture (such as a six loop nail knot). Theknot 51 can be held in thetube 20 during delivery/implantation using thedelivery device 10, 10'.Figure 4B illustrates theimplant 50 shown inFigure 4A with asupplemental suture 150. Thesupplemental suture 150 can be a #2 TiCron suture configured with Krackow stitches, such as about 6 on each side of thetear implant 50 in position and/or provide additional structural support at least during an initial healing period post surgery. However, thedelivery device 10, 10' can also be used to place other implants. As shown inFigure 4C , the delivery device may be configured to hold and deliver braidedribbons 50r with at least oneintegrated suture 250 that extends over the entire length L of the implant body and out from each end a distance L4. The extension length L4 can be between 1-500 mm or even greater, but is typically between about 20-400 mm. For additional description of collagen fiber ribbons with integrated sutures, see co-pending, co-assigned,U.S. Provisional Application Serial No. 61/450,179 US 8986378 B2 ). - Also, the
construct 50 can optionally include, e.g., be coated, impregnated and/or amalgamated with, a gel or other material. The coating may be to promote fibroblasts, and/or comprise one or more of an anti-inflammatory agent, an antibiotic or other therapeutic agent. Theconstruct 50 can be absorbed, resorbed and/or biodegradable over time. In some embodiments, theconstructs 50 can be configured to have similar or greater tensile strength, stiffness and dynamic flexibility as corresponding natural tissue, e.g., natural ligament or tendon fibers. Embodiments of the invention may be particularly suitable for augmenting, repairing or replacing tendons and ligaments. - In some embodiments, the fibers comprise collagen fibers formed in any suitable manner to be acceptable as a biomedical implant/construct.
- As noted above, in particular embodiments, the fibers can comprise NDGA-treated collagen. Suitable ways of forming NDGA-polymerized and/or - treated fibers are described in
U.S. Patent Nos. 6,565,960 and6,821,530 . Generally stated, bulk collagen can be solubilized by digestion with a protease, then extruded into a synthetic fiber. Properly processed NDGA polymerized fibers are biocompatible. After the polymerization process, the fibers can be washed in ethanol and phosphate buffered saline to remove cytotoxins due to leachable reaction products. - NDGA-treated collagen fibers are biocompatible and have desirable mechanical properties. For additional discussion of the NDGA polymerized fibers, see, Thomas J. Koob, Biomimetic approaches to Tendon Repair, Comparative Biochemistry and Physiology Part A 133 (2002) 1171-1192.
- In some embodiments, the collagen fibers may be high-strength. The term "high-strength" refers to fibers having an average tensile strength of at least about 150 MPa, such as between about 180 MPa and 350 MPa, and typically, for bovine-, porcine- or caprine-based "donor" collagen, between about 180 MPa and 280 MPa, such as between about 240-279 MPa (measured on average). The fibers may also have suitable stiffness and strain yield. In general, the fibers can have a stiffness of at least about 200 MPa (e.g., at least about 300, 400, 500, or 600 MPa), and a strain at failure of less than about 20% (e.g., less than about 15 or 10%).
- In particular embodiments, the fibers may be formed with a relatively thin diameter, such as, for example about a 0.07 mm dry diameter (on average) and about a 0.09 mm wet diameter (on average) or a dry diameter on average of about 0.08 mm and a wet diameter on average of about 0.13 mm. However, other sizes may be used.
- To make the collagen fibers, preparatory donor collagen material can be pepsin-derived or solubilized collagen that is processed/purified. The purified collagen preparatory material is dialyzed a plurality of times in a selected liquid for a desired period of time. The dialyzing is typically repeated three times. The dialyzing can be carried out against dionized (DI) water in a volume ratio of between about 30:1 to about 100:1, typically about 60:1, for between about 30-90 minutes, typically about 40 minutes. The dialyzing can form a substantially clear gel of collagen fibrils indicating good organization (substantially parallel fibrils), where opacity indicates less organization. The organization can help improve tensile strength of subsequently cross-linked fibers.
- The dialyzed collagen material can be incubated for a desired time before placing in a fiber-forming buffer. The dialyzed gel can be cross-linked to provide collagen fibers for medical constructs. The polymerization (e.g., cross-linking) can be carried out using NDGA or other suitable cross-linking agent and the resultant collagen fibers can be relatively thin, such as, for example, about 0.08 mm dry diameter (on average).
- The incubation may be for at least about 24 hours, typically 24-48 hours, and may be at room temperature of between about 15-30° C, typically about 25° C. The dialysis process can be used before cross-linking for subsequent use with any suitable cross-linking materials, such as, for example, to promote collagen organization, and the process is not limited to NDGA, but may be useful with other materials, including, for example, glutaraldehyde. For additional discussion of methods used to form high-strength NDGA treated collagen fibers, see,
U.S. Patent Application Serial No. 11/964,756 (US 8177839 ). - The
implants 50 can include swellable collagen fibers that have a cross-sectional size, on average, when dry, of between about 0.001 inches to about 0.2 inches (0.025 to 5 mm). The implant can include a number of strands of collagen-derived fibers such as between about 2-100, and the number of fibers per strand can be between about 2 to 1200. - In some embodiments, the
implant 50 may have between about 1-1000 yarns, typically between about 3-100 yarns some of which are weft and some of which are warp yarns. Theimplant 50 can be configured to have substantially the same physical thickness and/or configuration as the replaced or repaired tissue so as to not cause discomfort or physical abnormalities in structure. - As desired, the body of the
implant 50 can include a smooth outer sheath that may be formed by a coating, gel or other material. In particular embodiments, theimplant 50 can comprise polyglycolic acid, polylactic acid, or combinations of these or other substances. -
Figure 5 illustrates amedical kit 75 that includes thedelivery device 10, 10' and, optionally, at least oneconstruct 50, in a sealedpackage 88. Theconstruct 50 may be held dehydrated or partially hydrated in thepackage 88 or in another separate package (not shown). Thekit 75 may include a temperature warning so that theconstruct 50 is not exposed to unduly hot temperatures that may degrade the implant. Atemperature sensor 80 may optionally be included on or in thepackage 88 of thekit 75 to provide a visual or audible alert to a clinician as to any excessive or undue temperature exposure prior to implantation. Theconstruct 50 can be held in thetube 20 in thepackage 88. Theconstruct 50 can be inserted into thetube 20 of thedevice 10, 10' by the clinician in situ. This may also allow the clinician to select the desiredconstruct 50 fromconstructs 50 in a range of sizes that may be part of thepackage 88 or provided as separate content. Thedelivery device 10, 10' can be a "universal" delivery device that is configured to accommodate soft tissue implants in a range of sizes. -
Figure 6 is a flow diagram of exemplary operations that can be used to carry out embodiments of the present invention. A flexible tube with an open interior channel attached to a needle and having an elongate medical construct having a length with a portion held in the open interior channel is provided (block 100). The needle and tube are pulled through local structure (block 105). The tube and the medical construct are compressed in response to pressure applied from contact with local structure during the pulling step, thereby also pulling the portion of the medical construct held in the tube through the local structure (block 110). The medical construct is then separated from the tube after the compressing step by continuing to pull the tube after the tube has exited the local structure so that the medical construct is loosely held in the tube, thereby removing the tube from the medical construct and placing the medical implant in the body (block 115). - The local structure can optionally be soft tissue (block 107). The construct can optionally be loosely held in the tube and temporarily compressed by contact with the local structure (block 103).
- Although described herein primarily with respect to collagen-derived fiber implants, it is contemplated that the
delivery devices 10, 10' can deliver other types of implants. - The present invention is explained in greater detail in the following non-limiting Examples.
-
Figures 7 and8 show a delivery device 10' with thetube 20 as a heat shrink tube and with themedical construct 50 formed with braided NDGA-collagen fibers.Figure 7 illustrates that theheat shrink portion 20h extends over more than half of the length L1 of theneedle 15 and that the second segment of thetube 23 has a length that is between about 60-100% that of the implant. As shown, thesecond segment 23 has a longer length L2 than the length L1 of theneedle 15. - The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims.
Claims (14)
- A medical delivery device (10), comprising:a needle (15); anda tube (20) comprising a first segment (22) that is attached to the needle and a second, compressible and impermeable, segment (23) of greater diameter than that of the first segment, the second segment (23) extending rearwardly of the needle and defining a rearwardly open elongate interior channel adapted to hold a length of a flexible medical implant (50) therein,a flexible medical implant (50) having a length with a leading end and an opposing trailing end, wherein, before use, the leading end is loosely and releasably held inside the tube (20) spaced apart a distance (D) from a trailing end of the needle, and wherein 20-100% of the flexible medical implant length is located in the open elongate interior channel of the tube; characterized in that the tube has a first configuration during use where a portion of the second segment (23) is temporarily compressed by contact with soft tissue (90) during implantation so that only this compression tightly holds the implant therein;and in that the tube has a second configuration during use where the flexible medical implant (50) is disposed within the soft tissue (90) and when the needle (15) and the tube (20) are pulled out of and away from the soft tissue, the flexible medical implant is again releasably and loosely held inside the tube in such a way that the flexible medical implant is not in snug abutting contact with the inner surface of the tube, thereby enabling the flexible medical implant to slide out of the open trailing end of the tube .
- A medical device according to Claim 1, wherein at least 3 cm of the implant length is held in the compressible second segment interior channel, this length representing about 30% of the length of the implant.
- A medical device according to Claim 1 or 2, wherein the flexible medical implant (50) is a partially hydrated or dry twisted or braided collagen fiber implant.
- A medical device according to any preceding Claim, wherein the tube (20) has a forward end portion (20f) that resides in an interior chamber (15i) of a rearward portion of the needle.
- A medical device according to any of Claims 1 to 3, wherein the tube is swaged to the needle and has a smooth transition segment (t) from the needle to the tube to inhibit snagging when inserted through soft tissue during surgical use.
- A medical device according to any of Claims 1 to 3, wherein the needle has a length, and wherein the first segment (22) of the compressible tubing extends snugly against at least 1 cm of the length of the needle (15).
- A medical device according to any of Claims 1 to 3, wherein the needle is shank-less and has a constant-diameter outer wall (15w) upstream from a tip portion (151) thereof, and wherein an inner wall of the first segment (22) of the tube is affixed to the outer wall of the needle, and wherein the tube second segment (23) has a length that is sufficient to encase at least about 30% of the length of the implant held therein.
- A medical device according to Claim 7, wherein the tube is heat-shrink tubing that has been heated to shrink to conform and affix to the outer wall of the needle, and wherein the second segment (23) holds at least 40% of the implant length therein.
- A medical device according to any preceding Claim, wherein the medical implant (50) is a tendon or ligament repair implant having an integrated suture (250) that has suture ends that extend out from each end of the implant with at least 30% of the implant length being held in the second segment (23) of tube.
- A medical device according to any preceding Claim, wherein the medical implant held in the second segment of the tube is a length of substantially or entirely dry or partially hydrated biocompatible collagen fibers twisted or braided together that swell when exposed to a local fluidic environment in situ.
- A medical device according to any preceding Claim, wherein the medical implant held in the second segment of the tube comprises a plurality of fibers derived from soluble collagen that are in a dry or partially hydrated state and arranged as parallel long fibers that are at least about 1 cm long and are twisted and/or woven or braided together.
- A medical kit for a ligament or tendon repair, comprising a medical delivery device or kit according to any preceding claim, held in at least one sterile package.
- A method of assembling a medical delivery device or kit according to any preceding claim, comprising:providing the needle (15) attached to the compressible tube (20) having an open interior channel that extends a distance away from the needle; andslidably inserting the medical implant (50) comprising non-hydrated or partially hydrated braided and/or twisted collagen fibers into the open interior channel of the tube so that the implant is loosely held therein for intrabody placement using the needle and tube.
- A method according to claim 13, in which the needle is attached to the tube by heat-shrinking the tube onto the needle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US34529210P | 2010-05-17 | 2010-05-17 | |
PCT/US2011/036042 WO2011146292A2 (en) | 2010-05-17 | 2011-05-11 | Compressible tubes for placing implants and related medical kits and methods of using same |
Publications (3)
Publication Number | Publication Date |
---|---|
EP2571548A2 EP2571548A2 (en) | 2013-03-27 |
EP2571548A4 EP2571548A4 (en) | 2015-10-21 |
EP2571548B1 true EP2571548B1 (en) | 2018-04-18 |
Family
ID=44912438
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP11783973.8A Active EP2571548B1 (en) | 2010-05-17 | 2011-05-11 | Compressible tubes for placing implants and related medical kits and methods of using same |
Country Status (5)
Country | Link |
---|---|
US (2) | US9005285B2 (en) |
EP (1) | EP2571548B1 (en) |
AU (1) | AU2011256489B2 (en) |
CA (1) | CA2798712C (en) |
WO (1) | WO2011146292A2 (en) |
Families Citing this family (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8449612B2 (en) | 2009-11-16 | 2013-05-28 | Arthrocare Corporation | Graft pulley and methods of use |
US9694106B2 (en) * | 2011-07-11 | 2017-07-04 | Mimedx Group, Inc. | Synthetic collagen threads for cosmetic uses including skin wrinkle treatments and associated methods |
US20140186461A1 (en) | 2012-09-10 | 2014-07-03 | Alpha Tissue, Inc. | Human Amniotic Membrane Lyophilized Grafts |
US9155799B2 (en) | 2012-11-19 | 2015-10-13 | Mimedx Group, Inc. | Cross-linked collagen with at least one bound antimicrobial agent for in vivo release of the agent |
US8940684B2 (en) | 2012-11-19 | 2015-01-27 | Mimedx Group, Inc. | Cross-linked collagen comprising an antifungal agent |
US8946163B2 (en) | 2012-11-19 | 2015-02-03 | Mimedx Group, Inc. | Cross-linked collagen comprising metallic anticancer agents |
US10335433B2 (en) | 2013-04-10 | 2019-07-02 | Mimedx Group, Inc. | NDGA polymers and metal complexes thereof |
US9446142B2 (en) | 2013-05-28 | 2016-09-20 | Mimedx Group, Inc. | Polymer chelator conjugates |
EP3038630B1 (en) | 2013-08-30 | 2020-03-18 | MIMEDX Group Inc. | Micronized placental compositions comprising a chelator |
US9044301B1 (en) * | 2013-11-25 | 2015-06-02 | Innfocus, Inc. | Methods, systems and devices for treating glaucoma |
US9414941B2 (en) * | 2014-03-17 | 2016-08-16 | Otto J. Placik | System and method for inserting a pliable implant through a surgical incision using a multi-stage compression sleeve |
WO2017035365A1 (en) * | 2015-08-25 | 2017-03-02 | Endoshape, Inc. | Sleeve for delivery of embolic coil |
US9931196B2 (en) | 2015-08-26 | 2018-04-03 | Albert Einstein Healthcare Network | Connector for attaching tissue to bone |
BR112018070642A2 (en) | 2016-04-08 | 2019-02-05 | Allergan Inc | suction and injection device |
US10820900B2 (en) | 2017-01-24 | 2020-11-03 | Allergan Industrie Sas | Thread insertion devices |
US10595977B2 (en) * | 2017-01-24 | 2020-03-24 | Allergan Industrie, Sas | Thread insertion devices |
US10709444B2 (en) * | 2017-01-24 | 2020-07-14 | Allergan Industrie Sas | Thread insertion devices |
US10258447B2 (en) | 2017-01-24 | 2019-04-16 | Allergan Industrie Sas | Thread insertion devices |
US10265151B2 (en) | 2017-01-24 | 2019-04-23 | Allergan Industrie Sas | Thread insertion devices |
US11051799B2 (en) | 2017-09-01 | 2021-07-06 | Wright Medical Technology, Inc. | Augmented suture construct for syndesmotic stabilization |
US11583609B2 (en) | 2018-08-08 | 2023-02-21 | Mimedx Group, Inc. | Collagen constructs and methods of making the same |
AU2019378866A1 (en) * | 2018-11-13 | 2021-06-03 | Genesis Biologics, Inc. | Systems and methods of preparing a graft |
US20220023029A1 (en) * | 2020-10-06 | 2022-01-27 | Ali Moradi | Prosthesis to replace a flexor tendon pulley |
Family Cites Families (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US1981651A (en) * | 1933-06-23 | 1934-11-20 | Owen J Logan | Surgical needle and suture |
US2748774A (en) * | 1953-12-17 | 1956-06-05 | Ohio Commw Eng Co | Collagen strands and method of treating |
US3212502A (en) * | 1963-01-25 | 1965-10-19 | Hu C Myers | Knotless adhesive impregnated sutures and method of use thereof |
US4050100A (en) * | 1976-05-12 | 1977-09-27 | Barry Robert J | Permanently implanted hair piece attaching means |
US4265246A (en) * | 1979-05-30 | 1981-05-05 | Barry Cosmetic Suture Company, Inc. | Sterile cosmetic suture and scalp implant for attaching hair pieces |
US4392495A (en) * | 1981-08-31 | 1983-07-12 | Bayers Jon Herbert | Apparatus for and method of suturing tissue |
KR950000058B1 (en) * | 1986-06-12 | 1995-01-09 | 가부시끼가이샤 뮤텍크 | Suturing needle with suture and method of producing the same |
US5123911A (en) * | 1989-09-27 | 1992-06-23 | United States Surgical Corporation | Method for attaching a surgical needle to a suture |
US5102418A (en) * | 1989-09-27 | 1992-04-07 | United States Surgical Corporation | Method for attaching a surgical needle to a suture |
US5280674A (en) * | 1989-09-27 | 1994-01-25 | United States Surgical Corporation | Apparatus for attaching a surgical needle to a suture |
US5059212A (en) * | 1989-09-27 | 1991-10-22 | United States Surgical Corporation | Surgical needle-suture attachment for controlled separation of the needle from the suture |
US5259845A (en) | 1989-09-27 | 1993-11-09 | United States Surgical Corporation | Surgical needle-suture attachment with a lubricated suture tip for controlled suture release |
US5378469A (en) * | 1990-04-06 | 1995-01-03 | Organogenesis, Inc. | Collagen threads |
US5116358A (en) * | 1990-07-23 | 1992-05-26 | United States Surgical Corporation | Combined surgical needle-suture device possessing a controlled suture separation feature |
US5306288A (en) * | 1990-09-05 | 1994-04-26 | United States Surgical Corporation | Combined surgical needle-suture device |
CA2049103C (en) * | 1990-09-06 | 1996-10-01 | Royce Lewis | Implant assist apparatus |
US5368595A (en) * | 1990-09-06 | 1994-11-29 | United States Surgical Corporation | Implant assist apparatus |
US5152769A (en) * | 1991-11-04 | 1992-10-06 | Will Baber | Apparatus for laparoscopic suturing with improved suture needle |
FR2743294B1 (en) * | 1996-01-05 | 1998-04-03 | Ethnor | IMPLANTABLE BONE ANCHORING DEVICE OF A LIGAMENTARY OR OSTEO-LIGAMENTARY TRANSPLANT, PARTICULARLY FOR THE REPAIR OF THE ANTERIOR CROSS LIGAMENT OF THE KNEE |
US6059800A (en) * | 1997-09-10 | 2000-05-09 | Applied Medical Resources Corporation | Suturing apparatus and method |
US6342060B1 (en) * | 1998-12-08 | 2002-01-29 | Brian D. Adams | Tendon passing device and method |
US6499486B1 (en) * | 1999-07-29 | 2002-12-31 | Ethicon, Inc. | Method for reconstructing a ligament |
US6565960B2 (en) | 2000-06-01 | 2003-05-20 | Shriners Hospital Of Children | Polymer composite compositions |
US6500184B1 (en) * | 2001-01-31 | 2002-12-31 | Yung C. Chan | Suturing apparatus and method of suturing |
US20050033362A1 (en) | 2001-09-13 | 2005-02-10 | Grafton R. Donald | High strength suture with collagen fibers |
US7892256B2 (en) | 2001-09-13 | 2011-02-22 | Arthrex, Inc. | High strength suture tape |
US7585311B2 (en) | 2004-06-02 | 2009-09-08 | Kfx Medical Corporation | System and method for attaching soft tissue to bone |
US20060058890A1 (en) * | 2004-09-16 | 2006-03-16 | Lesh Michael D | Methods for soft tissue augmentation |
US7850985B2 (en) * | 2005-07-05 | 2010-12-14 | Cook Biotech Incorporated | Tissue augmentation devices and methods |
CA2674470C (en) | 2006-12-27 | 2016-05-10 | Shriners Hospitals For Children | Woven and/or braided fiber implants and methods of making same |
AU2008219006B2 (en) * | 2007-02-20 | 2013-04-18 | Shriners Hospitals For Children | In vivo hydraulic fixation including bio-rivets using biocompatible expandable fibers |
EP2291143B1 (en) * | 2008-05-16 | 2020-07-08 | Mimedx, Inc. | Medical constructs of twisted lengths of collagen fibers and methods of making same |
WO2009151453A1 (en) * | 2008-06-12 | 2009-12-17 | Core Essense Orthopaedics, Llc | A method and apparatus for repairing a tendon or ligament |
KR101712560B1 (en) * | 2008-06-24 | 2017-03-06 | 바이오엑티브 써지컬, 아이엔씨. | Surgical sutures incorporated with stem cells or other bioactive materials |
EP2683864B1 (en) | 2011-03-08 | 2016-08-17 | MiMedx Group, Inc. | Collagen fiber ribbons with integrated fixation sutures and methods of making the same |
-
2011
- 2011-05-11 WO PCT/US2011/036042 patent/WO2011146292A2/en active Application Filing
- 2011-05-11 US US13/105,353 patent/US9005285B2/en active Active
- 2011-05-11 EP EP11783973.8A patent/EP2571548B1/en active Active
- 2011-05-11 CA CA2798712A patent/CA2798712C/en active Active
- 2011-05-11 AU AU2011256489A patent/AU2011256489B2/en active Active
-
2015
- 2015-03-11 US US14/644,739 patent/US9610151B2/en active Active
Non-Patent Citations (1)
Title |
---|
None * |
Also Published As
Publication number | Publication date |
---|---|
CA2798712C (en) | 2018-07-17 |
US20110282447A1 (en) | 2011-11-17 |
EP2571548A2 (en) | 2013-03-27 |
WO2011146292A2 (en) | 2011-11-24 |
AU2011256489B2 (en) | 2015-01-22 |
US9005285B2 (en) | 2015-04-14 |
AU2011256489A1 (en) | 2012-11-29 |
US20150196384A1 (en) | 2015-07-16 |
CA2798712A1 (en) | 2011-11-24 |
WO2011146292A3 (en) | 2012-03-15 |
US9610151B2 (en) | 2017-04-04 |
EP2571548A4 (en) | 2015-10-21 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9610151B2 (en) | Methods of using compressible tubes for placing implants | |
US10258327B2 (en) | Biostaples suitable for wrist, hand and other ligament replacements or repairs | |
US7901455B2 (en) | Tendon or ligament bioprostheses and methods of making same | |
US9078775B2 (en) | Methods of making collagen fiber medical constructs and related medical constructs, including nerve guides and patches | |
US20230055112A1 (en) | Collagen Construct and Method for Producing the Collagen Construct |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
17P | Request for examination filed |
Effective date: 20121217 |
|
AK | Designated contracting states |
Kind code of ref document: A2 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
DAX | Request for extension of the european patent (deleted) | ||
A4 | Supplementary search report drawn up and despatched |
Effective date: 20150923 |
|
RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61B 17/11 20060101ALN20150917BHEP Ipc: A61F 2/82 20130101ALN20150917BHEP Ipc: A61B 17/00 20060101ALN20150917BHEP Ipc: A61F 2/08 20060101ALI20150917BHEP Ipc: A61B 17/06 20060101AFI20150917BHEP Ipc: A61B 17/34 20060101ALN20150917BHEP |
|
RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: MIMEDX GROUP, INC. |
|
17Q | First examination report despatched |
Effective date: 20170217 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R079 Ref document number: 602011047617 Country of ref document: DE Free format text: PREVIOUS MAIN CLASS: A61M0005140000 Ipc: A61B0017060000 |
|
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61B 17/34 20060101ALN20171011BHEP Ipc: A61B 17/11 20060101ALN20171011BHEP Ipc: A61F 2/82 20130101ALN20171011BHEP Ipc: A61L 27/36 20060101ALN20171011BHEP Ipc: A61L 27/24 20060101ALN20171011BHEP Ipc: A61B 17/06 20060101AFI20171011BHEP Ipc: A61B 17/00 20060101ALN20171011BHEP Ipc: A61F 2/08 20060101ALI20171011BHEP |
|
INTG | Intention to grant announced |
Effective date: 20171103 |
|
GRAS | Grant fee paid |
Free format text: ORIGINAL CODE: EPIDOSNIGR3 |
|
GRAA | (expected) grant |
Free format text: ORIGINAL CODE: 0009210 |
|
AK | Designated contracting states |
Kind code of ref document: B1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
REG | Reference to a national code |
Ref country code: GB Ref legal event code: FG4D |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: EP |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: REF Ref document number: 989562 Country of ref document: AT Kind code of ref document: T Effective date: 20180515 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FG4D |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R096 Ref document number: 602011047617 Country of ref document: DE |
|
REG | Reference to a national code |
Ref country code: FR Ref legal event code: PLFP Year of fee payment: 8 |
|
REG | Reference to a national code |
Ref country code: NL Ref legal event code: MP Effective date: 20180418 |
|
REG | Reference to a national code |
Ref country code: LT Ref legal event code: MG4D |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: NL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: ES Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: LT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: SE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: PL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: AL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: NO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180718 Ref country code: BG Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180718 Ref country code: FI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: HR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: LV Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: GR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180719 Ref country code: RS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: PL |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: MK05 Ref document number: 989562 Country of ref document: AT Kind code of ref document: T Effective date: 20180418 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: PT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180820 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R097 Ref document number: 602011047617 Country of ref document: DE |
|
REG | Reference to a national code |
Ref country code: BE Ref legal event code: MM Effective date: 20180531 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: MC Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: DK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: AT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: EE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: CZ Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: RO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: MM4A |
|
PLBE | No opposition filed within time limit |
Free format text: ORIGINAL CODE: 0009261 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CH Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180531 Ref country code: IT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: LI Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180531 Ref country code: SM Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
26N | No opposition filed |
Effective date: 20190121 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LU Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180511 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180511 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: BE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180531 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180511 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: TR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: HU Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO Effective date: 20110511 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CY Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180418 Ref country code: MK Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180418 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180818 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: FR Payment date: 20230525 Year of fee payment: 13 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: GB Payment date: 20240527 Year of fee payment: 14 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: DE Payment date: 20240530 Year of fee payment: 14 |